Department: Azzur of CA, LLC
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.
With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance, and validation services specifically geared for the complexities of life science.
We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Willing to work hands on with multiple clients throughout Southern California
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
Lead a process transfer TEAM in the planning, execution and
implementation of downstream (preferred) and/or upstream processes which
include but are not limited to:
- UF/DF clarification/concentration (TFF/Dead-End UF)
- Ion Exchange Chromatography, IEX (QSFF, SP- Sepharose, )
- Mixed mode/multi-modal chromatography (Hydroxyapatite)
- Affinity Chromatography (Protein G)
- Hydrophobic Interaction, HIC Chromatography (Phenyl Sepharose)
- Size Exclusion Chromatography, SEC (Superdex 200)
- Cell Culture Roller Bottle/Spinner Cell Expansion and Analysis
- Lead a process transfer TEAM in the planning, execution and
implementation of analytical assays which include but are not limited to:
- ELISA (Activity, Host Cell Protein)
- UV Spectrophotometry (Protein Concentration)
- LC Assays
- Size Exclusion Analysis
- Glycan Analysis/Sialic Acid Content
- High Performance Anion Exchange Analysis
- Cell Culture Analytics
- Provide oversight and conduct of a project throughout its life, including method development, method validation, and sample analysis.
- Serve as Principal Investigator.
- Work closely with Technical Writing and QA to ensure projects are completed on schedule.
- Review validation and bioanalytical reports for completeness. Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
- Work with the customer to resolve sample discrepancies.
- Monitor the progress of all assigned projects and alert management if work falls behind schedule.
- Provide regular project status updates to management.
- Participate in weekly scheduling and revenue update meetings and provide updates on project progress.
- Submit accurate weekly assessment of resource requirements for scheduling purposes.
- Prepare validation and sample analysis plans.
- Review data (run binders, data tables, etc) for regulatory compliance and scientific quality.
- Address issues from QC and QA review for run binders.
- Conduct thorough investigations of all failed runs.
- Lead method troubleshooting investigations.
- Provide project trackers for client communications and lead regular teleconferences to discuss project progress.
- Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.
Required Knowledge, Skills, and Abilities
- Ability to achieve results through collaborative efforts with others.
- Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.
- Experienced in sample extraction and routine laboratory procedures.
- Understanding of method development and validation of assays.
- Ability to interact with external and internal clients, and work to objectives/timelines.
- Excellent attention to detail and communication skills.
- Ability to provide verbally communicated or draft procedures.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Minimum Required Education and Experience
- Bachelor's Degree scientific field
- 7-10 years’ related experience. Equivalent combination of education, training, and experience in GLP laboratory environment.
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ